South Expansion Update 12408

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Clinical Trials Updates Novel Funding Methods
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Cancer Focus Singular Mission
To contribute to the prevention cure of
cancer.
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Accrual to Therapeutic Trials
1,439
1,357
942
817
755
664
591
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Site Objectives

• Access to new agents
• Clinical study
• Correlative Laboratory projects
• Publications
• Market differentiation

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Sponsor Objectives

• Evaluate agent fast
• Time is money
• Fast fail philosophy
• Quick activation
• Quality data
• Evaluable patients
• Regulatory compliance

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Clinical Trial AgreementContractual Elements

• Parties to the Agreement
• Publications
• Publicity
• Intellectual Property
• Indemnification
• Governing Law

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Clinical Trial AgreementContractual Elements

• Indirect Costs
• Clinical Trial Amendments
• Clinical Trial Extensions
• Invoicing and Payments
• Trial Close-Out

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Master Clinical Trials Agreement

• Provides the terms and conditions governing all
  clinical studies performed for that sponsor
  within a certain time period
• Task orders detail each study specific items
• payments milestones
• Initially more complex to negotiate, but each
  subsequent trial can be activated much faster

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Budgets

• Usually funded on a per-patient basis
• provisions for pro-rated payment for patients who
  do not complete the study
• All costs necessary to conduct the study,
  including
• Salaries
• Procedures
• Services
• Supplies and indirect costs

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Budget Planning

• Pre-trial budget planning secures high payments
  during sponsor negotiations
• Billing grid translates budget into actionable
  charge document
• Regular audits of billing practices, ensuring
  that only experimental costs are billed to
  trials.

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Set the bar higher
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Enrollment

• Physicians drive patient participation, but often
  neglect to discuss trial participation
• Patients are more likely to join a clinical trial
  if advised by their physicians
• Cancer patients misperceptions about trial
  protocols and procedures.
• Patient expectations about clinical trials risks
  and benefits may also affect their willingness to
  participate.
• Education initiatives about open trials
• provide regular updates about open trials
• Website updates

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Educate Payors

• proactively educating payers about trial costs
  and coverage requirements.
• educational meetings with payers
• alert payers of trial involvement
• electronic tracking system that stores standard
  of care costs, research budgets, enrolled
  patients, and trial details

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New Industry Collaborative Paradigm

• Shift from testing companies products in clinical
  or laboratory setting
• TO joint development on all levels

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Approach Total Cancer Care Personalized Medicine
Project

• A large prospective translational research
  project with patient consent
• Collect, relate, and interpret clinical data and
  molecular data from thousands of patients
• Tumor, blood, urine samples
• Clinical data (risk factors, therapies, outcomes)
• Identify molecular signatures for prognosis
• Personalize therapy and follow-up
• Right care, right patient
• Create evidence based approach

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Merck Moffitt Collaboration

• Original Objective
• Develop Gene Expression signatures for at least
  six tumor types within 3-5 years, using sumor
  samples from both primary resections and
  metastatic biopsies

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Key Elements of the TCC Collaboration

• Patients consented to TCC protocol to allow
  collection and sharing of
• Tumor samples
• Health data including outcomes
• Provision for re-contact for future studies
• Acquire sufficient sample to be able to identify
  signatures
• Expand the TCC protocol to community sites (16
  targeted)

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Key Elements of the TCC Collaboration

• Tissue collection and banking
• Strict criteria (SOPs) to ensure high tissue
  quality
• Consistent processing and storage
• Genetic profiling
• Longitudinal data repository
• Information associated with these tumors
• medical history
• risk factors treatment
• response

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Key Business Elements TCC Collaboration

• Substantial Merck funding leveraged to
• Develop new MCC corporate entity (M2Gen)
• State of Florida funding of 15 million
• City County Funding 20 million
• Included 30 acres of new land

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Long Range Objectives TCC Collaboration

• Develop Gene Expression Signatures for at least
  six tumor types within 3-5 years, using Tumor
  samples from both primary resections and
  metastatic biopsies.

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Long Range Objectives TCC Collaboration

• Develop and sustain the Collaboration Database, a
  state-of-the-art data warehouse that integrates
  discreet data from clinical and research source
  systems.
• At minimum, this system should provide
• Adequate storage capacity for the TCC Protocols
  clinical and genomic data
• A de-identification engine
• HIPAA compliant security
• Reporting capability that supports TCC decision
  making requirements

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Long Range Objectives TCC Collaboration

• Develop a bio-repository that supports the
  Collaboration Program and the TCC Protocol.
• Identify patients that harbor specific targets
  for potential enrollment into early phase
  clinical trials. Initiate population based trial
  matching studies.

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Subsequent successesTCC Collaboration

• Support of MCC scientists doing related work
• Pathway development
• Development new mouse models (xenographs)
• Drug discovery
• Joint development of new signatures
• Original goal response to Merck drugs
• now expanded to include
• Non responders in 3-4 tumor types
• Predicting non-response to BMT (myeloma)
• MCC access to Merck Pipeline
• Access to all phase 1 and FIM studies
• Co-development of protocols

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Key Elements of Moffitt/Pfizer TCC Collaboration

• Collaborative 3 year project with two distinct
  quality of care projects
• First project is a retrospective chart review of
  cancer patients with breast, colon and lung
  cancer to determine adherence to NCCN clinical
  practice guidelines
• Second project provides a retrospective chart
  review of newly diagnosed metastatic cancer
  patients to evaluate access to and participation
  in clinical trials.
• Both projects will be conducted at Moffitt and at
  selected sites affiliates

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Key Elements of Moffitt/Pfizer TCC Collaboration

• Goal is to gather patient information
  prospectively using technology to follow patients
  longitudinally for health outcomes analysis
• A by-product of these projects will be to
  strengthen support for clinical trials affiliates
  by the addition of infrastructure
• Funding 10.3 million over three years

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Questions?